Drugs

Change FDA Approach to Antibiotic Approval: Column

National Center for Health Research president Diana Zuckerman and George Washington University and University of Maryland professor John Powers III say FDA should be focusing on how new antibiotics work in patients rather than looking at how they kill bacteria in a test tube. Writing in a STAT First Opinion column, Zuckerman and Powers argue that the agency “should approve new antibiotics that are proven to help save the lives of patients with both resistant and susceptible bacterial infections compared to currently available drugs.”

They write that FDA currently approves drugs based on assumptions from test tube studies instead of studies of patients who would use the drug in the real world.

“As a result,” they say, “new drugs may be no more effective than older, cheaper drugs that are already available, even though the new drugs are much more expensive. That has been true for decades as numerous studies show.”

The article lists these three reasons why the focus on killing bacteria in a test tube is misguided:

antibiotics can save lives even if they kill only most bacteria and not all of them;
antibiotics that kill more bacteria sometimes have so many unpleasant side effects that patients quickly stop taking them; and
the patients who die from infections are often older and have immune systems that aren’t functioning as well as they used to.

“But the bigger problem with FDA’s approach of focusing on killing germs in a test tube is that antibiotics might not actually be the best or only way to fight some infections,” the authors say. “Yet FDA’s attention has been focused on getting more antibiotics to market using ‘smaller and shorter’ studies with less evidence, not better drugs that improve the lives of patients.”

EDITOR’S CLARIFICATION: All drugs, including antibiotics, have to show FDA proof of clinical (human) effectiveness, although accelerated approvals for highly important new drugs and biologics can be granted on the basis of surrogate endpoints before human studies have been completed.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

Read more

Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome